雷卡西马布:首次获得批准
1Springer Nature, Private Bag 65901, Mairangi Bay, Auckland, 0754, New Zealand. dru@adis.com.
Drugs
|June 22, 2025
概括
针对PCSK9的新型抗体雷卡西马布在中国首次获得批准,用于治疗高胆固醇血症和混合性脂质失调症. 这标志着降脂疗法在不对他类药物有反应的患者中取得了重大进展.
科学领域:
- 心血管药理学心血管药理学
- 免疫学 免疫学 免疫学
- 药物开发 药物开发
背景情况:
- 高胆固醇血症和混合性失脂血症是心血管疾病的重要危险因素.
- 目前的降脂疗法,包括他类药物,并不能在所有患者中达到目标低密度脂蛋白胆固醇 (LDL-C) 水平.
- 蛋白转化酶亚素/素9型 (PCSK9) 是LDL-C代谢的关键调节者.
研究的目的:
- 总结一下recaticimab的发展里程碑,这是一种针对PCSK9.9的人性化单克隆抗体.
- 为了突出雷卡西马布在高胆固醇血症和混合性脂质失调症的监管批准.
主要方法:
- 雷卡西马布是一种人性化的单克隆免疫球蛋白G1抗体.
- 它向PCSK9,抑制其与LDL受体的相互作用.
- 开发涉及临床前和临床研究 (细节未提供摘要).
主要成果:
- 雷卡西马布于2025年1月8日在中国获得首次批准.
- 在未达到LDL-C目标的成年人中被批准作为初级高胆固醇血症和混合性脂质失调症的饮食和他类药物的辅助剂.
- 已被批准作为非家族性高胆固醇血症和混合性脂质失调症的单疗法,以降低LDL-C,总胆固醇和阿波利波蛋白B.
结论:
- 雷卡西马布代表了治疗高胆固醇血症和混合性脂质失调症的新疗法.
- 批准标志着PCSK9抑制剂开发的里程碑.
- 这一进步为需要额外的降脂治疗的患者提供了新的策略.
更多相关视频
07:25In Vitro Methods for Comparing Target Binding and CDC Induction Between Therapeutic Antibodies: Applications in Biosimilarity Analysis
Published on: May 4, 2017
17.8K
08:46A Real-time Potency Assay for Chimeric Antigen Receptor T Cells Targeting Solid and Hematological Cancer Cells
Published on: November 12, 2019
53.5K
相关概念视频
Drugs for Treatment of Crohn's Disease in IBD Using Biologic Agents: Anti-TNF
240
Tumor Necrosis Factor (TNF), a proinflammatory cytokine, contributes significantly to the inflammation seen in Crohn's disease. It exists as soluble TNF and membrane-bound TNF, with actions mediated through TNF receptors (TNFR). TNFR activation leads to the release of proinflammatory cytokines, T-cell activation, collagen production, and leukocyte migration, all contributing to inflammation in Crohn's disease. Anti-TNF monoclonal antibodies, namely infliximab (Remicade), adalimumab...
240
Drugs for Treatment of Crohn's Disease in IBD Using Immunomodulatory Agents
278
Crohn's disease is an inflammatory bowel disorder marked by chronic inflammation of the GI tract. Various treatment strategies for Crohn's disease are employed, such as immunomodulatory agents, glucocorticoids, and biologics or anti-TNF therapy. Azathioprine (Imuran), a commonly used immunomodulatory drug for Crohn's disease, is converted in the body to mercaptopurine, which inhibits purine biosynthesis and cell proliferation. Both are utilized in severe cases of Inflammatory Bowel...
278
Drugs for Treatment of Crohn's Disease in IBD Using Glucocorticoids
210
Glucocorticoids, a class of anti-inflammatory drugs, are pivotal in treating moderate to severe Crohn's disease by inducing remission. They exhibit their anti-inflammatory action by inhibiting the production of inflammatory cytokines such as tumor necrosis factor (TNF)-α, interleukin (IL)-1, and chemokines like IL-8. In addition, they reduce the expression of inflammatory cell adhesion molecules and inhibit gene transcription of nitric oxide synthase, phospholipase A2, cyclooxygenase-2...
210
![Dynamic Imaging of Chimeric Antigen Receptor T Cells with [18F]Tetrafluoroborate Positron Emission Tomography/Computed Tomography](/_next/image?url=https%3A%2F%2Fcloudfront.jove.com%2FCDNSource%2Fteasers%2F62334.jpg&w=3840&q=50)